时间：2015-03-20 11:23:32
in the recent period, “tying-in” medical devices have occurred frequently in the medical device market. pharmaceutical companies sell blood glucose meters or blood glucose test strips for “tying” blood collection needles, selling condoms for “tying” human lubricating fluids, and fitness equipment stores “tying” second-class medical equipment such as cervical vertebra therapy equipment and oxide. none of the companies have a medical device business license, but these medical device products are sold in disguise in the form of "tying sales". if the channels for purchasing medical devices that are "tying-sold" to consumers are illegal and irregular, the quality of the products will be difficult to guarantee, which will become a huge hidden danger to the health of the people.
the "regulations on medical device supervision and administration" stipulates: "the establishment of type 2 and type 3 medical device business enterprises shall be reviewed and approved by the drug regulatory department of the people's government of the province, autonomous region, and municipality directly under the central government, and a medical device business license should be issued." according to relevant regulations, unlicensed business operations shall be ordered to cease operations, illegally operated products and illegal income shall be confiscated, and penalties shall be imposed. however, the person in charge of the "tying" medical device company argued that these medical device products were given to consumers in the form of "tying", as evidenced by the tying advertisement posted in the store and the purchase list indicating the word gift. there is no illegal operation. the existing medical device supervision regulations do not provide for the behavior of “tying medical devices”, and law enforcement officers are at a loss as to what to do.
at present, the regulations for the supervision and administration of drug circulation have clearly stipulated that enterprises shall not give prescription drugs or class a non-prescription drugs to the public in the form of buying drugs as gifts, or buying commodities as gifts. the author believes that for disguised sales behaviors such as “tying” medical devices, medical device regulations should be in line with drug regulations, and timely supplements and amendments should be made. tying and donation of medical devices during operation is strictly prohibited to ensure the safety of the masses' use of devices.
